Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors
NCT ID: NCT00274911
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2004-02-29
Brief Summary
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PURPOSE: This phase II trial is studying how well giving radiation therapy followed by combination chemotherapy works in treating young patients with supratentorial primitive neuroectodermal tumors.
Detailed Description
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Primary
* Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors.
Secondary
* Determine overall and relapse-free survival of patients treated with HART followed by adjuvant combination chemotherapy comprising lomustine, cisplatin, and vincristine.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
* Radiotherapy: Patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks.
* Adjuvant combination chemotherapy: Six weeks after the last radiotherapy dose, patients receive oral lomustine once and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 . Treatment repeats every 6 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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cisplatin
lomustine
vincristine sulfate
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically proven nonpineal supratentorial primitive neuroectodermal tumors
* No supratentorial atypical teratoid/rhabdoid tumors or medulloepitheliomas
* Localized or metastatic disease
* Metastatic disease is defined as unequivocal evidence of supratentorial metastases and/or spinal metastases on pre-operative or postoperative MRI scan OR tumor cells seen on cytospin analysis of lumbar cerebrospinal fluid (stage M1) performed between 15 days and 21 days after surgery
* Has undergone surgical resection within the past 4-6 weeks
PATIENT CHARACTERISTICS:
* Able to cooperate with twice daily fractions of radiotherapy
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Neurologically stable (or improving) during the week before starting radiotherapy
* Lansky performance status 30-100% (for patients 1 to 16 years of age) OR
* Karnofsky performance status 30-100% (for patients over 16 years of age)
* Must be able to comply with the chemotherapy protocol (e.g., no hearing loss, renal impairment)
* No presence of active uncontrolled infection
* No previous malignant disease
* Not pregnant or nursing
* No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
PRIOR CONCURRENT THERAPY:
* No previous chemotherapy or radiotherapy
* The patient should not be receiving steroids, if possible, at the start of radiotherapy or should be on a stable or reducing dose of steroids during the week before starting radiotherapy
3 Years
18 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Frank Saran, MD
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Christopher Chandler, MD
Role:
King's College Hospital NHS Trust
Roger Taylor, MD
Role:
Cookridge Hospital
David Ellison, MD
Role:
Northern Centre for Cancer Treatment at Newcastle General Hospital
Barry Pizer, MD
Role:
Royal Liverpool Children's Hospital, Alder Hey
Locations
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Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Royal London Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000454540
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20580
Identifier Type: -
Identifier Source: secondary_id
CCLG-CNS-2004-01
Identifier Type: -
Identifier Source: org_study_id